UCB (BRUSSELS, Belgium) and Otsuka Pharmaceuticals Co, Ltd (TOKYO, Japan) announced that they have signed a collaboration agreement to promote UCB's anti-TNFα drug, Cimzia® for the treatment of Crohn's Disease in Japan, the second largest pharmaceutical market in the world. The companies will also codevelop and copromote Cimzia in other indications.
UCB will receive upfront and milestone payments of up to EUR 113 million (~$176 million) as well as funding for the clinical development of Cimzia. The companies plan to submit a filing dossier for Cimzia in Crohn's disease to the Japanese Pharmaceuticals and Medical Devices Agency by early 2009.
Cimzia (certolizumab pegol) is the first and only PEGylated anti-TNFα agent. Cimzia has a high affinity for human TNFα, selectively neutralizing the pathophysiological effects of TNFα. UCB is developing Cimzia in Crohn's disease, rheumatoid arthritis, and other autoimmune disease indications. In April 2008, UCB announced that the US FDA approved the drug for reducing signs and symptoms of Crohn's disease and maintaining clinical response in adult patients with moderate-to-severe active disease who have had an inadequate response to conventional therapy. In RA, where approval has yet to be granted, the drug has been shown to inhibit joint damage as soon as 16 weeks after the start of treatment.
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